Recall Z-1864-2025 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NxStage Medical Inc
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
| Date | May 28, 2025 (initiated Apr 28, 2025) |
| Status | Open, Classified |
| Reason | Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment. |
| Root cause | Under Investigation by firm |
| Action | NxStage notified consignees via mail on 04/28/2025. Consignees were instructed to check inventory for affected units and cease use if any are on hand, complete and return the response form, and contact NxStage Customer Service to arrange return of all affected units. |
| Quantity | 115,465 cases (230,930 units) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc., Dec 22, 2005 |